Biomarkers in Multiple Myeloma
- Conditions
- Hematological PatientsChemotherapyNewly Diagnosed Multiple Myeloma
- Registration Number
- NCT05259553
- Brief Summary
The association between multiple myeloma (MM) and venous thromboembolism (VTE) is well known. Indeed, the incidence of VTE is increased in patients with newly diagnosed MM and in patients treated by immunomodulatory drugs in combination with glucocorticoids. Moreover, the clinical outcome of MM is supposed to be correlated to the risk of thrombosis. At the biological level, a number of hemostasis abnormalities participate in increasing VTE incidence. Yet, data on predictive biomarkers linked to VTE are limited.
- Detailed Description
There is a need to discern predictive biomarkers in order to better identify patients at risk of developing VTE, to decipher the mechanisms by which myeloma treatments interfere and in fine to choose an adequate thromboprophylaxis. In this context, it is important to document the precise expression of coagulation factors and to profile point-of-care tests for coagulation monitoring in newly diagnosed MM patients, before and during treatment. In addition, thromboprophylaxis is systematically included in therapeutic MM strategies, especially direct oral anticoagulants, without knowing whether potential drug interactions are occurring. This study aims at evaluating and validating predictive biomarkers of VTE in MM, and at identifying patients whose thromboprophylaxis is required and may potentially be adjusted because of drug interactions.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 70
- Patient affiliated to a social security regimen or beneficiary of the same
- Signed written informed consent form
- Confirmed diagnosis of de novo multiple myeloma, non-previously treated and requiring treatment.
- Pregnant women
- Patient under guardianship or deprived of his liberty or any condition that may affect the patient's ability to understand and sign the informed consent
- Refusing participation
- Patient whose follow-up or life expectancy is less than 6 months.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Level of factor VIII in newly diagnosed and untreated MM 24 months Measurement of factor VIII on plasma from newly diagnosed MM patients before the initiation of chemotherapy
Level of D-Dimers in newly diagnosed and untreated MM 24 months Measurement of D-Dimers on plasma from newly diagnosed MM patients before the initiation of chemotherapy
Level of pro-coagulant phospholipids in newly diagnosed and untreated MM 24 months Measurement of pro-coagulant phospholipids on plasma from newly diagnosed MM patients before the initiation of chemotherapy
Level of thrombin generation in newly diagnosed and untreated MM 24 months Measurement of thrombin on plasma from newly diagnosed MM patients before the initiation of chemotherapy
- Secondary Outcome Measures
Name Time Method Association between biomarkers (thrombin, factor VIII, D-Dimers, pro-coagulant phospholipids) and VTE onset 24 months Correlation between the plasma level of biomarkers and clinical data
Association between biomarkers (thrombin, factor VIII, D-Dimers, pro-coagulant phospholipids) and MM outcome 24 months Correlation between the plasma level of biomarkers and clinical data
Evaluation of the exposition of Apixaban (Eliquis®) 24 months Plasma level of Apixaban in MM treated patients
Evolution of biomarkers (thrombin, factor VIII, D-Dimers, pro-coagulant phospholipids) at 3 months post-treatment 24 months Correlation between the plasma level of biomarkers and clinical data
Trial Locations
- Locations (2)
Hospices Civils de Lyon
🇫🇷Lyon, France
CHU de Saint-Etienne
🇫🇷Saint-Étienne, France
Hospices Civils de Lyon🇫🇷Lyon, FranceLionel Karlin, MDContact